Cleanroom Classification

Cleanroom classification refers to the categorization of cleanrooms based on their cleanliness levels, as defined by international standards such as ISO 14644. Cleanrooms are classified into different classes, ranging from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean). The classification is determined by the allowable levels of airborne particles per cubic meter at specified particle sizes.

Facilities must adhere to cleanroom classifications appropriate for their industry and operational requirements to ensure the controlled environment meets the necessary cleanliness levels.

Cleanroom Standards

Cleanroom standards are guidelines and specifications set by regulatory bodies to ensure the quality and cleanliness of controlled environments. These standards define the acceptable levels of airborne particles, temperature, humidity, and other factors within cleanrooms. Adhering to cleanroom standards is crucial for industries such as pharmaceuticals, electronics, and healthcare to maintain product quality and prevent contamination.

Common cleanroom standards include ISO 14644 for particle cleanliness, and ISO 14698 for microbial cleanliness. Facilities must regularly monitor and validate their cleanrooms to ensure compliance with these standards.

Clean Room Design

Clean room design is the process of planning and creating controlled environments with low levels of airborne contaminants. This design process involves considerations such as airflow patterns, air filtration systems, material selection, and layout to meet specific cleanliness standards. Clean room design is crucial in industries where the quality and reliability of processes depend on minimizing contamination, such as pharmaceuticals, electronics, and biotechnology.

The success of clean room design contributes to the effectiveness of controlled environments and the quality of processes conducted within.

Clean Room Grade

Clean room grade refers to the level of cleanliness maintained within a controlled environment, often classified based on international standards such as ISO standards. Clean room grades range from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean), with each class specifying the allowable levels of airborne particles at specified particle sizes. The clean room grade is a critical parameter, especially in industries such as electronics, pharmaceuticals, and manufacturing, where product quality depends on controlling contamination.

Understanding and maintaining the appropriate clean room grade is essential for the success of controlled environments.